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Navina™ Smart System

FDA UDI

Class II (US FDA UDI)

by Wellspect AB

Identity

Trade Name
Navina™ Smart System FDA UDI
Generic Name
Powered rectal/colostomy irrigation system FDA UDI
Device Name
Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina case. Non Sterile Device. Rx Only. FDA UDI
Model / Reference
69109 FDA UDI
Description
Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina case. Non Sterile Device. Rx Only. FDA UDI

Identifiers

Catalog Number
6910940 FDA UDI
Primary DI / UDI-DI
07333387052625 FDA UDI
FDA Product Code
KNT FDA UDI
FCE FDA UDI
GMDN Term
Powered rectal/colostomy irrigation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
876.5210 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Powered rectal/colostomy irrigation system

Navina™ Smart System by Wellspect AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Powered rectal/colostomy irrigation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wellspect AB

Sources (1)

  • FDA UDI 4a373761-aae7-49bf-995d-d543b53d13c1 36 fields · synced May 30, 2026